Are pharma companies preparing for Brexit day?
A survey has revealed about 58% of centrally authorised marketing authorisation (MA) holders expect to complete regulatory processes to ensure MAs remain valid following Brexit.
The survey, by the European Medicines Agency (EMA), aimed to identify potential shortages. It showed some 88 human products manufactured in the UK only may not have valid MAs following Brexit. Companies producing 10% of the 694 products did not reply.
Preparations could include a transfer of the MA to a legal entity established in the European Economic Area (EEA). A similar move for qualified persons for pharmacovigilance and pharmacovigilance system master files, and manufacturing sites is also likely to be required.